MAUDE Adverse Event Report: ALUNG TECHNOLOGIES, INC. HEMOLUNG RAS; EXTRACORPOREAL SYSTEM FOR CARBON DIOXIDE REMOVAL

Model Number HL-CR4-01-000-RECERT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Anemia (1706)

Event Date 03/08/2021

Event Type  Injury  

Event Description

Alung technologies, inc.Received a report of a patient experiencing anemia during hemolung therapy.Two units of blood was given to the patient.Hemolung therapy was not discontinued as a result of this event.

Manufacturer Narrative

This patient information was not provided.Alung technologies, inc.Manufactures the hemolung ras and catheter.The incident occurred in pittsburgh, pennsylvania.Through review of the expanded access form, it was reported that the patient experienced anemia during hemolung therapy.Two units of blood were given to the patient and therapy was not discontinued as a result of this issue.The data log from therapy has been retrieved and reviewed by both clinical and software engineering staff.No abnormalities were noted within the co2 removal and blood flow graphs.Therapy was provided as intended.No capa was opened because of this event.Anemia is a known possible complication that can occur during extracorporeal therapy.The treating physician was able to fully realize their clinical goals and significant benefit of therapy was realized.Examination of the controller data log shows that therapy was provided as intended.Alung technologies, inc.Will continue to monitor any issues as they are reported.This mdr is being filed in response to a retrospective view of all alung technologies, inc.Complaints, which identified that the reporting decision for this complaint was not correct.This mdr is being filed retrospectively to correct the error in the reporting decision.

• Brand Name: HEMOLUNG RAS
• Type of Device: EXTRACORPOREAL SYSTEM FOR CARBON DIOXIDE REMOVAL
• Manufacturer (Section D): ALUNG TECHNOLOGIES, INC.; 2500 jane st; suite 1; pittsburgh PA 15203
• Manufacturer Contact: ryan coyle ; 2500 jane st; suite 1; pittsburgh, PA 15203
• MDR Report Key: 16211946
• MDR Text Key: 307765235
• Report Number: 3009763347-2023-00096
• Device Sequence Number: 1
• Product Code: QOH
• UDI-Device Identifier: 00850046004346
• UDI-Public: (01)00850046004346(17)180827
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: DEN210006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: HL-CR4-01-000-RECERT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 65 YR
• Patient Sex: Female